Cardiac ArrestCPRNCT00650962
Pre-shock Cardiopulmonary Resuscitation to Patients With Out-of-hospital Resuscitation, A Randomised Clinical Trial
A study testing cardiopulmonary resuscitation and Rhythm analysis in people with Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. Pre-shock cardiopulmonary resuscitation might benefit the survival of out-of-hospital cardiac patients with ventricular fibrillation / ventricular tachycardia in a post-hoc analysis of a prehospital trial conducted in Europe (L.Wik,2002). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- cardiopulmonary resuscitation and Rhythm analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,666 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with out-of-hospital cardiac arrest
Who cannot join
- Trauma
- Age < 18y/o
- Airway obstruction
- Submersion
- Sign of obvious death
- existing do not resuscitate (DNAR) order
- family refusal
- preceding CPR by BLS teams for longer than 2 minutes.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Emergency Medicine, National Taiwan University Hospital
Taipei
About this study
Official title: Does Longer Pre-shock Cardiopulmonary Resuscitation Improve the Outcome of Patients With Out-of-hospital Cardiac Arrest? A Randomized Control Trial.
- Pre-shock cardiopulmonary resuscitation might benefit the survival of out-of-hospital cardiac patients with ventricular fibrillation / ventricular tachycardia in a post-hoc analysis of a prehospital trial conducted in Europe (L.Wik,2002). However, it's effectiveness in the Asian countries, where most firstly recorded rhythm in out-of-hospital cardiac arrests patients were asystole/pulseless electric activity rather than ventricular fibrillation / ventricular tachycardia, were not explored yet.
- This trial was designed to exam if pre-shock cardiopulmonary resuscitation by emergency medical technicians improves the outcome of all out-of-hospital cardiac arrest patients in an Asian metropolitan city.
Read the detailed description
- Different from data from the Western countries, non-shockable rhythm (Asystole/pulseless electric activity) was responsible for most out-of-hospital cardiac arrest patients(80%~90%) in metropolitan Taipei.
- Response time in Taipei emergency medical service was longer than 5 minutes.
- Bystander cardiopulmonary resuscitation rate were relatively low in Taipei.
- Cardiopulmonary resuscitation is the only known method to save out-of-hospital cardiac arrest patients with asystole/pulseless electric activity. For those suffered from ventricular fibrillation/ ventricular tachycardia,previous studies revealed pre-shock cardiopulmonary resuscitation may have the potential to improve the outcome.
- Study hypothesis: Compared with current standard resuscitative sequence (basic life support protocol in Guideline 2005), longer pre-shock cardiopulmonary resuscitation provided to all out-of-hospital cardiac arrest patients in Taipei may improve the outcome of them.
- Conditions
- Cardiac Arrest
- Being tested
- cardiopulmonary resuscitation, Rhythm analysis
- Keywords
- CPR, Preshock CPR, OHCA, EMS
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary resuscitationOther
Also called automatic external defibrillator
10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED
Rhythm analysisOther
Also called cardiopulmonary resuscitation, automatic external defibrillator
Rhythm analysis as soon as AED is ready
| Study group | Role | What they receive |
|---|---|---|
| CPR first | Active comparator | Compression First (CF) Receives: Other: cardiopulmonary resuscitation |
| Analysis First | Active comparator | Rhythm analysis first Receives: Other: Rhythm analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained ROSC >= 2 hours
Measured: 180 days
Secondary outcomes (3)
surival to ICU admission
Measured: 180 days
survival to hospital discharge
Measured: 180 days
Rates of good neurology recovery (CPC 1 &2)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,666 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Matthew Huei-Ming Ma, MD, PHD, Principal investigator, Department of Emergency Medicine, NTUH.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650962
- Sponsor's protocol ID
- 200710019R
- Other IDs
- NSC 962314B002018
- Acronym
- CPR
- Status last verified
- Dec 2011
- First submitted
- 30 Mar 2008
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Longer Pre-shock Cardiopulmonary Resuscitation Improve the Outcome of Patients With Out-of-hospital Cardiac Arrest? A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT00650962
- Acronym / sponsor ID
- CPR / 200710019R
- Conditions
- Cardiac Arrest
- Keywords
- CPR, Preshock CPR, OHCA, EMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,666 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Pre-shock cardiopulmonary resuscitation might benefit the survival of out-of-hospital cardiac patients with ventricular fibrillation / ventricular tachycardia in a post-hoc analysis of a prehospital trial conducted in Europe (L.Wik,2002). However, it's effectiveness in the Asian countries, where most firstly recorded rhythm in out-of-hospital cardiac arrests patients were asystole/pulseless electric activity rather than ventricular fibrillation / ventricular tachycardia, were not explored yet.
- This trial was designed to exam if pre-shock cardiopulmonary resuscitation by emergency medical technicians improves the outcome of all out-of-hospital cardiac arrest patients in an Asian metropolitan city.
Detailed description
- Different from data from the Western countries, non-shockable rhythm (Asystole/pulseless electric activity) was responsible for most out-of-hospital cardiac arrest patients(80%~90%) in metropolitan Taipei.
- Response time in Taipei emergency medical service was longer than 5 minutes.
- Bystander cardiopulmonary resuscitation rate were relatively low in Taipei.
- Cardiopulmonary resuscitation is the only known method to save out-of-hospital cardiac arrest patients with asystole/pulseless electric activity. For those suffered from ventricular fibrillation/ ventricular tachycardia,previous studies revealed pre-shock cardiopulmonary resuscitation may have the potential to improve the outcome.
- Study hypothesis: Compared with current standard resuscitative sequence (basic life support protocol in Guideline 2005), longer pre-shock cardiopulmonary resuscitation provided to all out-of-hospital cardiac arrest patients in Taipei may improve the outcome of them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPR first | Active comparator | Other: cardiopulmonary resuscitationCompression First (CF) |
| Analysis First | Active comparator | Other: Rhythm analysisRhythm analysis first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with out-of-hospital cardiac arrest
Key exclusion criteria (8 listed)
- Trauma
- Age < 18y/o
- Airway obstruction
- Submersion
- Sign of obvious death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary resuscitationAlso: automatic external defibrillator10 cycles of 30:2 cardiopulmonary resuscitation before rhythm analysis by AED | Other | CPR first |
| Rhythm analysisAlso: cardiopulmonary resuscitation, automatic external defibrillatorRhythm analysis as soon as AED is ready | Other | Analysis First |
Primary outcome
Sustained ROSC >= 2 hours
Time frame: 180 days
3 secondary outcomes
surival to ICU admission
Time frame: 180 days
survival to hospital discharge
Time frame: 180 days
Rates of good neurology recovery (CPC 1 &2)
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Huei-Ming Ma, MD, PHD principal investigator
Department of Emergency Medicine, NTUH.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary resuscitation and Rhythm analysis in people with Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained ROSC >= 2 hours (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.